Status:
TERMINATED
Evaluation of Efficacy and Safety of AVE5530 in Patients With Primary Hypercholesterolemia
Lead Sponsor:
Sanofi
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The present study is aiming at assessing the efficacy and safety of AVE5530 (25mg and 50mg) in a double-blind comparison with placebo in the management of patients with primary hypercholesterolemia. T...
Detailed Description
The study will include a 2-week pre-randomization placebo lead-in phase and a double-blind treatment period of at least 12 months and can be variably extended up to approximately 18 months.
Eligibility Criteria
Inclusion
- Adults with high cholesterol levels either not receiving or willing and able to discontinue ongoing lipid-lowering therapy
Exclusion
- LDL-C levels \> 250 mg/dL (6.48 mmol/L)
- Triglycerides levels \> 350mg/dL (3.95 mmol/L)
- Conditions / situations such as:
- presence of any clinically significant uncontrolled endocrine disease known to influence lipids levels
- Active liver disease
- High estimated risk of Coronary Heart Disease
- Recent history of congestive heart failure , of unstable angina pectoris, myocardial infarction, coronary bypass surgery or angioplasty, or Unstable or severe peripheral artery disease
- Positive test for Hepatitis B surface antigen and/or Hepatitis C antibody or Known to be Human Immunodeficient Virus (HIV) positive
- Pregnant or breast-feeding women,
- Women of childbearing potential not protected by effective contraceptive method of birth control (including oral contraceptives) and/or who are unwilling or unable to be tested for pregnancy prior to exposure to the Investigational Product.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
826 Patients enrolled
Trial Details
Trial ID
NCT00718965
Start Date
July 1 2008
End Date
June 1 2009
Last Update
May 16 2016
Active Locations (2)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis Administrative Office
San Juan, Puerto Rico